FDA record · Obesity and weight management
Foundayo (orforglipron calcium)
What FDA's own documents say about Foundayo: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
- Sponsor
- Eli Lilly and Co.
- Application
- NDA 220934
- First approved
- April 1, 2026
- Status
- Approved
- Read from
- 12 FDA documents, 1,002 pages
What it is approved for
“FOUNDAYO™ is a GLP-1 receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.”
Prescribing information, supplement 003 · PDF p. 1 · fda.gov ↗
Trials FDA reviewed
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| ATTAIN-1J2A-MC-GZGP | NCT05869903 | 3 | 323 | 7 of 12 |
| ATTAIN-2J2A-MC-GZGQ | NCT05872620 | 3 | 312 | 7 of 12 |
| ATTAIN-JJ2A-JE-GZPD | NCT05931380 | 3 | 62 | 4 of 12 |
| J2A-MC-GZGA | NCT03929744 | 1 | 37 | 2 of 12 |
| J2A-MC-GZPG | NCT06186622 | 1 | 27 | 1 of 12 |
| J2A-MC-GZPI | NCT06440980 | 1 | 26 | 2 of 12 |
| J2A-MC-GZGI | NCT05051579 | 2 | 22 | 2 of 12 |
| J2A-MC-GZGC | NCT04426474 | 1 | 20 | 2 of 12 |
| J2A-MC-GZGN | NCT05841238 | 1 | 16 | 2 of 12 |
| J2A-MC-GZGM | NCT05469126 | 1 | 15 | 2 of 12 |
| ACHIEVE-4J2A-MC-GZGS | NCT05803421 | 3 | 12 | 5 of 12 |
| J2A-MC-GZPJ | NCT06370728 | 1 | 12 | 1 of 12 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Safety
Most common adverse reactions
“Most common adverse reactions, reported in >=5% of patients treated with FOUNDAYO, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss.”
Prescribing information, supplement 003 · PDF p. 1 · fda.gov ↗
Adverse events the documents discuss most
- thyroid C-cell tumors 168 mentions
- hypersensitivity 163 mentions
- hypoglycemia 161 mentions
- nausea 133 mentions
- vomiting 132 mentions
- diarrhea 106 mentions
- death 106 mentions
- acute pancreatitis 105 mentions
FDA documents read
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval220934Orig1s000lbl.pdf | April 2, 2026 | 26 | archived copy | c315c017fbda |
| Approval letter220934Orig1s000ltr.pdf | April 2, 2026 | 12 | cef1196da5e1 | |
| Administrative Correspondence220934Orig1s000AdminCorres.pdf | May 15, 2026 | 58 | archived copy | c1daa691927f |
| Approval Letter220934Orig1s000Approv.pdf | May 15, 2026 | 15 | archived copy | 049d21ef7a90 |
| Chemistry Review220934Orig1s000ChemR.pdf | May 15, 2026 | 83 | 784b6cea5bff | |
| Prescribing Information (Label)220934Orig1s000Lbl.pdf | May 15, 2026 | 49 | ea34cf41309d | |
| Multi-disciplinary Review220934Orig1s000MultidisciplineR.pdf | May 15, 2026 | 564 | ab9f15b75d5b | |
| Proprietary Name Review220934Orig1s000NameR.pdf | May 15, 2026 | 7 | archived copy | 104a85d8e71d |
| Officer/Employee List220934Orig1s000OEList.pdf | May 15, 2026 | 3 | bac82c859f60 | |
| Other Reviews220934Orig1s000OtherR.pdf | May 15, 2026 | 143 | 00d5f9652e0c | |
| Risk Assessment / REMS Review220934Orig1s000RiskR.pdf | May 15, 2026 | 16 | 12e5a18090db | |
| Prescribing information, supplement 003220934s003lbl.pdf | August 4, 2026 | 26 | b64aa952e583 |
Checked against FDA's copies on September 29, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.
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